Pain, PostoperativePhase 2/3NCT06077422
Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain
A Phase 2/3 study testing bupivacaine liposome injectable suspension and Bupivacaine Hydrochloride in people with Pain, Postoperative and Opioid Use, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Opioid Use, Perioperative Complication
- What is being tested?
- bupivacaine liposome injectable suspension and Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to 5 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years-no upper age limit)
- Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. bypass graft) at single academic medical center (in and out-patients).
Who cannot join
- Patients will be excluded if they:
- Are currently on pain medication or pain regimen for chronic pain condition
- Convert to sternotomy (for thoracotomies)
- Require, upon intraoperative discovery and surgeon's decision, the need for an unplanned secondary procedure other than the originally scheduled index operation
- Undergo emergent surgery
- Are non-English speaking (The majority of the PI's patient population speak English. As a pilot study the investigators cannot afford to enroll non-English speaking subjects due to time, personnel, and financial constraints.)
Show all 11Show fewer
- Mechanical circulatory support (MCS)
- Vasoactive medications
- Intubated
- Active infection
- Patients otherwise deemed ineligible for ESP block by the investigators due to safety concerns.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Control Trial to Assess the Efficacy of Preoperative Erector Spinae Blocks on Cardiac Surgery Postoperative Outcomes
The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.
Read the detailed description
Postoperative pain is a major concern for patients after cardiovascular surgery.
With an increasing emphasis on improving perioperative care arising from evidence-based protocols such as Enhanced Recovery After Surgery (ERAS), reducing postoperative pain not only increases patient satisfaction, but also decreases postoperative complications and improves outcomes. Reduced postoperative pain also decreases rates of pneumonia and time on mechanical ventilation, in the ICU, or in the hospital. Importantly, decreasing postoperative pain can also reduce high dose opioid usage, the established method of managing postoperative pain, thereby decreasing rates of nausea/vomiting, intubation time, and mortality. Methods of reducing postoperative pain, such as neuraxial anesthesia and deep plexus blocks, are associated with an increased risk of epidural hematoma; an alternate solution, therefore, is using fascial plane blocks.
Since 2018, our institution is one of very few that uses pre-operative fascial plane blocks for cardiac surgery patients, implementing bilateral plane blocks for the sternotomy approach and unilateral plane blocks for the right mini-thoracotomy approach. Results from these blocks have been quite favorable but not yet validated.
A study in which subjects are randomized to not receive an ESP block preoperatively would raise concerns regarding equipoise. Therefore, this study is designed to better understand the overall effects of these blocks by comparing FDA approved medications, Exparel (current practice at RWJUH) and Marcaine. Marcaine (0.25% bupivacaine HCl) has an onset of action on the order of seconds and generally within one minute from the time of injection, and an effect duration of roughly seven hours. Exparel is a commercially available extended-release formulation of liposomal bupivacaine, which extends the effect duration to an upward of 72 hours from the time of injection with similarly immediate onset of action. Several studies have compared local injections of Marcaine (plain bupivacaine) with Exparel (liposomal bupivacaine) in the setting of inguinal hernia repair, knee arthroplasty, breast augmentation, and hemorrhoidectomy, with results favoring the use of liposomal bupivacaine based on improvements in subjective pain at the initial postoperative pain assessment.(6) Clinical trials are currently underway, investigating the effect of liposomal bupivacaine for local anesthesia and compared with epidural anesthesia in thoracoscopic surgery. In a recent clinical trial published in the Journal of the American Medical Association (JAMA), patients undergoing cardiothoracic or vascular surgery subjected to truncal incisions did not demonstrate a significant benefit with respect to pain control or adjunctive opioid usage when treated with liposomal bupivacaine over plain bupivacaine via local injection. Still, a gap in the literature exists with respect to the use of liposomal bupivacaine versus plain bupivacaine for erector spinae plane block in the setting of sternotomy. The aim of this prospective study is to determine the impact of preoperative fascial plane blocks with Exparel compared to Marcaine on outcomes following cardiac procedures.
- Being tested
- bupivacaine liposome injectable suspension, Bupivacaine Hydrochloride
- Keywords
- plane block, sternotomy, thoracotomy, cardiac, surgery, postoperative, pain, anesthesia, opioid, pragmatic trial
- Medical subject headings
- Pain, Postoperative, Heart Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine liposome injectable suspensionDrug
Also called Exparel
Bupivacaine liposome injectable suspension (Exparel) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.
Bupivacaine HydrochlorideDrug
Also called Marcaine
Bupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | The experimental medication (Exparel) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight.
For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine). Receives: Drug: bupivacaine liposome injectable suspension |
| Marcaine | Active comparator | The active comparator medication (Marcaine) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight.
For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoracotomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine). Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Postoperative opioid consumption within first five postoperative days, reported as average mg/day in morphine equivalents.
Measured: Postoperative days 0 through 5
Secondary outcomes (7)
Postoperative nonopioid analgesic consumption
Postoperative non-opioid analgesic (Pregabalin, Gabapentin, selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), Ketorolac, Tramadol, Ibuprofen, and Acetaminophen) consumption within first five postoperative days, reported as average mg/day.
Measured: Postoperative days 0 through 5
Inpatient postoperative pain score
Pain scores through postoperative day five, using the standard Numeric Rating Scale (NRS), wherein a score of 0 corresponds to "no pain," 5 to "moderate pain," and 10 to "worst possible pain," reported as mean score over all five days.
Measured: Postoperative days 0 through 5
Outpatient postoperative pain score
Single pain score at follow-up visit, using the standard Numeric Rating Scale (NRS), wherein a score of 0 corresponds to "no pain," 5 to "moderate pain," and 10 to "worst possible pain."
Measured: Obtained within 30 days following surgery
30-day mortality rate
Proportion of patients who expire within 30 postoperative days from the index operation.
Measured: Through postoperative day 30
30-day major morbidity rate
Proportion of patients who experience the composite outcome of major morbidity, defined as the occurrence of any of the following within 30 postoperative days from the index operation: pneumonia, respiratory failure with ventilatory support >48h, pulmonary embolism (PE), deep vein thrombosis (DVT), multi-organ dysfunction syndrome, postoperative myocardial infarction (MI), acute renal failure requiring renal replacement therapy, cerebrovascular accident (CVA), infection of wound or line or urinary tract infection (UTI), readmission, sustained postoperative atrial or ventricular arrhythmia, new postoperative atrial fibrillation, exacerbation of pre-existing atrial fibrillation
Measured: Through postoperative day 30
Postoperative qualify of life
Measured as change on the 12-item Short Form Survey (SF-12) from preoperative baseline to followup. Scores on the SF-12 range from 0 to 100, with higher scores indicating better physical and mental health.
Measured: Within the range of 30 days prior to surgery to 30 days after surgery
Hospitalization cost
Before-insurance cost of hospitalization and treatment.
Measured: Study duration, limited to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start11 Jan 2024
- Primary completion11 Jan 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Leonard Y. Lee, MD, Rutgers, The State University of New Jersey
- Investigators
- Leonard Y Lee, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School, Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077422
- Sponsor's protocol ID
- Pro2022001580
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toscano A, Barbero C, Capuano P, Costamagna A, Pocar M, Trompeo A, Pasero D, Rinaldi M, Brazzi L. Chronic postsurgical pain and quality of life after right minithoracotomy mitral valve operations. J Card Surg. 2022 Jun;37(6):1585-1590. doi: 10.1111/jocs.16400. Epub 2022 Mar 11.
PubMed 35274774Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PubMed 30052229Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.
PubMed 30665850Song K, Xu Q, Knott VH, Zhao CB, Clifford SP, Kong M, Slaughter MS, Huang Y, Huang J. Liposomal Bupivacaine-Based Erector Spinae Block for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 May;35(5):1555-1559. doi: 10.1053/j.jvca.2020.09.115. Epub 2020 Sep 20. No abstract available.
PubMed 33046362Collins JB, Song J, Mahabir RC. Onset and duration of intradermal mixtures of bupivacaine and lidocaine with epinephrine. Can J Plast Surg. 2013 Spring;21(1):51-3. doi: 10.1177/229255031302100112.
PubMed 24431939Gadsden J, Long WJ. Time to Analgesia Onset and Pharmacokinetics After Separate and Combined Administration of Liposome Bupivacaine and Bupivacaine HCl: Considerations for Clinicians. Open Orthop J. 2016 Apr 12;10:94-104. doi: 10.2174/1874325001610010094. eCollection 2016.
PubMed 27347237Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753.
PubMed 33724391Yoo J, Pepe RJ, Nithikasem S, Laraia KN, Yang NK, Lee LY. Liposomal bupivacaine versus bupivacaine hydrochloride erector spinae plane blocks in cardiac surgery: protocol for a pragmatic randomized controlled trial. Trials. 2026 Apr 2;27(1):270. doi: 10.1186/s13063-026-09620-8.
PubMed 41923260
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Assess the Efficacy of Preoperative Erector Spinae Blocks on Cardiac Surgery Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT06077422
- Acronym / sponsor ID
- Pro2022001580
- Keywords
- plane block, sternotomy, thoracotomy, cardiac, surgery, postoperative, pain, anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 11 Jan 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.
Detailed description
Postoperative pain is a major concern for patients after cardiovascular surgery.
With an increasing emphasis on improving perioperative care arising from evidence-based protocols such as Enhanced Recovery After Surgery (ERAS), reducing postoperative pain not only increases patient satisfaction, but also decreases postoperative complications and improves outcomes. Reduced postoperative pain also decreases rates of pneumonia and time on mechanical ventilation, in the ICU, or in the hospital. Importantly, decreasing postoperative pain can also reduce high dose opioid usage, the established method of managing postoperative pain, thereby decreasing rates of nausea/vomiting, intubation time, and mortality. Methods of reducing postoperative pain, such as neuraxial anesthesia and deep plexus blocks, are associated with an increased risk of epidural hematoma; an alternate solution, therefore, is using fascial plane blocks.
Since 2018, our institution is one of very few that uses pre-operative fascial plane blocks for cardiac surgery patients, implementing bilateral plane blocks for the sternotomy approach and unilateral plane blocks for the right mini-thoracotomy approach. Results from these blocks have been quite favorable but not yet validated.
A study in which subjects are randomized to not receive an ESP block preoperatively would raise concerns regarding equipoise. Therefore, this study is designed to better understand the overall effects of these blocks by comparing FDA approved medications, Exparel (current practice at RWJUH) and Marcaine. Marcaine (0.25% bupivacaine HCl) has an onset of action on the order of seconds and generally within one minute from the time of injection, and an effect duration of roughly seven hours. Exparel is a commercially available extended-release formulation of liposomal bupivacaine, which extends the effect duration to an upward of 72 hours from the time of injection with similarly immediate onset of action. Several studies have compared local injections of Marcaine (plain bupivacaine) with Exparel (liposomal bupivacaine) in the setting of inguinal hernia repair, knee arthroplasty, breast augmentation, and hemorrhoidectomy, with results favoring the use of liposomal bupivacaine based on improvements in subjective pain at the initial postoperative pain assessment.(6) Clinical trials are currently underway, investigating the effect of liposomal bupivacaine for local anesthesia and compared with epidural anesthesia in thoracoscopic surgery. In a recent clinical trial published in the Journal of the American Medical Association (JAMA), patients undergoing cardiothoracic or vascular surgery subjected to truncal incisions did not demonstrate a significant benefit with respect to pain control or adjunctive opioid usage when treated with liposomal bupivacaine over plain bupivacaine via local injection. Still, a gap in the literature exists with respect to the use of liposomal bupivacaine versus plain bupivacaine for erector spinae plane block in the setting of sternotomy. The aim of this prospective study is to determine the impact of preoperative fascial plane blocks with Exparel compared to Marcaine on outcomes following cardiac procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: bupivacaine liposome injectable suspensionThe experimental medication (Exparel) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine). |
| Marcaine | Active comparator | Drug: Bupivacaine HydrochlorideThe active comparator medication (Marcaine) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoracotomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (18 years-no upper age limit)
- Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. bypass graft) at single academic medical center (in and out-patients).
Key exclusion criteria (11 listed)
- Are currently on pain medication or pain regimen for chronic pain condition
- Convert to sternotomy (for thoracotomies)
- Require, upon intraoperative discovery and surgeon's decision, the need for an unplanned secondary procedure other than the originally scheduled index operation
- Undergo emergent surgery
- Are non-English speaking (The majority of the PI's patient population speak English. As a pilot study the investigators cannot afford to enroll non-English speaking subjects due to time, personnel, and financial constraints.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaine liposome injectable suspensionAlso: ExparelBupivacaine liposome injectable suspension (Exparel) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy. | Drug | Exparel |
| Bupivacaine HydrochlorideAlso: MarcaineBupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy. | Drug | Marcaine |
Primary outcome
Postoperative opioid consumption
Time frame: Postoperative days 0 through 5
Postoperative opioid consumption within first five postoperative days, reported as average mg/day in morphine equivalents.
7 secondary outcomes
Postoperative nonopioid analgesic consumption
Time frame: Postoperative days 0 through 5
Inpatient postoperative pain score
Time frame: Postoperative days 0 through 5
Outpatient postoperative pain score
Time frame: Obtained within 30 days following surgery
30-day mortality rate
Time frame: Through postoperative day 30
30-day major morbidity rate
Time frame: Through postoperative day 30
Postoperative qualify of life
Time frame: Within the range of 30 days prior to surgery to 30 days after surgery
Hospitalization cost
Time frame: Study duration, limited to one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 35274774Toscano A, Barbero C, Capuano P, Costamagna A, Pocar M, Trompeo A, Pasero D, Rinaldi M, Brazzi L. Chronic postsurgical pain and quality of life after right minithoracotomy mitral valve operations. J Card Surg. 2022 Jun;37(6):1585-1590. doi: 10.1111/jocs.16400. Epub 2022 Mar 11.
- Background: PubMed 30052229Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
- Background: PubMed 30665850Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.
- Background: PubMed 33046362Song K, Xu Q, Knott VH, Zhao CB, Clifford SP, Kong M, Slaughter MS, Huang Y, Huang J. Liposomal Bupivacaine-Based Erector Spinae Block for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 May;35(5):1555-1559. doi: 10.1053/j.jvca.2020.09.115. Epub 2020 Sep 20. No abstract available.
- Background: PubMed 24431939Collins JB, Song J, Mahabir RC. Onset and duration of intradermal mixtures of bupivacaine and lidocaine with epinephrine. Can J Plast Surg. 2013 Spring;21(1):51-3. doi: 10.1177/229255031302100112.
- Background: PubMed 27347237Gadsden J, Long WJ. Time to Analgesia Onset and Pharmacokinetics After Separate and Combined Administration of Liposome Bupivacaine and Bupivacaine HCl: Considerations for Clinicians. Open Orthop J. 2016 Apr 12;10:94-104. doi: 10.2174/1874325001610010094. eCollection 2016.
- Background: PubMed 33724391Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753.
- Derived from this study: PubMed 41923260Yoo J, Pepe RJ, Nithikasem S, Laraia KN, Yang NK, Lee LY. Liposomal bupivacaine versus bupivacaine hydrochloride erector spinae plane blocks in cardiac surgery: protocol for a pragmatic randomized controlled trial. Trials. 2026 Apr 2;27(1):270. doi: 10.1186/s13063-026-09620-8.
- Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (BEMP)Link provided by the sponsor.
- Study of Exparel Versus Epidural for Pain Control After ThoracotomyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonard Y Lee, MD principal investigator
Rutgers Robert Wood Johnson Medical School, Dept of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bupivacaine liposome injectable suspension and Bupivacaine Hydrochloride in people with Pain, Postoperative and Opioid Use, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: Postoperative days 0 through 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077422, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.